Regulatory Affairs Specialist: CMC & Post-Marketing

ITech Consult AG; Basel; On-site; CHF 100,000 - 140,000; Full time

Job summary

Roche in Basel is seeking a Regulatory Specialist (CMC) on a contract basis to manage Health Authority interactions related to CMC information for IND, IMPD and NDA/BLA/MAA filings, and to drive pre-submission meetings with global authorities and partners. You will engage with affiliates and stakeholders across the product lifecycle in a dynamic, cross-functional environment.

The ideal candidate holds a Bachelor's degree in a relevant field, C1 English fluency, and 3+ years of regulatory affairs

Responsibilities

• Handle Health Authority interactions pertaining to CMC information for IND, IMPD and NDA/BLA/MAA filings.
• Lead informational and pre-submission meetings with global Health Authorities and partners.

Job description

Roche in Basel is seeking a Regulatory Specialist (CMC) on a contract basis to manage Health Authority interactions related to CMC information for IND, IMPD and NDA/BLA/MAA filings, and to drive pre-submission meetings with global authorities and partners. You will engage with affiliates and stakeholders across the product lifecycle in a dynamic, cross-functional environment.

The ideal candidate holds a Bachelor's degree in a relevant field, C1 English fluency, and 3+ years of regulatory affairs